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临床试验/NCT05530525
NCT05530525已完成不适用

Psychometric Evaluation of Commonly Used Measures in Patients With Stroke Using Medical Record Review

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
The National Institutes of Health Stroke Scale

研究概览

简要总结

Purposes: The aim of this study is to examine the psychometric properties (e.g. test-retest reliability, random measurement error, practice effect, and responsiveness) of the commonly used measures in patients with stroke using medical record review.

The investigators anticipate reviewing 1000 stroke patients' medical record from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist.

详细描述

The investigators anticipate reviewing 1000 stroke patients' medical record (from 2018/6/1 to 2021/6/30) from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist. The study was approved by the local institutional review board. Because the targeted populations for examining the test-retest reliability and responsiveness were different, the inclusion criteria were listed separately below.

Test-retest reliability Chronic stroke patients' data was reviewed to examine the test-retest reliability. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset ≥ 6 months (first and recurrent stroke included).

Responsiveness Subacute stroke patients' data was reviewed to examine the responsiveness. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset < 3 months (first and recurrent stroke included).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The National Institutes of Health Stroke Scale

时间窗: The repeated assessments were performed at an one-month interval.

The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

The computerized adaptive testing system of the functional assessment of stroke

时间窗: The repeated assessments were performed at an one-month interval.

The Computerized Adaptive Testing system of the Functional Assessment of Stroke comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper limb, 11 items from the Fugl-Meyer Assessment-Lower limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. These items evaluate motor control, postural control, and activity of daily living functions in patients with stroke. Results are automatically reported as Rasch scores (i.e., the minimum and maximum values are negative and positive infinity, respectively). A higher score indicates greater physical functions.

The Barthel Index

时间窗: The repeated assessments were performed at an one-month interval.

The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

次要结局

未报告次要终点

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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